Home NDC 50090-1564 zaleplon
Product NDC 50090-1564
11-digit product format 500901564
Labeler code 50090
Product ID 50090-1564_b6f10404-69b2-47b0-970e-bf392d4a6ebd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name zaleplon
Dosage form CAPSULE
Route ORAL
Labeler A-S Medication Solutions
Application ANDA078989
Marketing category ANDA
Marketing start 2009-05-05
Substance ZALEPLON
Active strength 10 mg/1
Pharmacologic classes Central Nervous System Depression [PE], GABA A Agonists [MoA], gamma-Aminobutyric Acid A Receptor Agonist [EPC]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 50090-1564 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 50090-1564 50090-1564-1 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 50090-1564 50090-1564-0 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078989-001 ZALEPLON ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 A078989-002 ZALEPLON ZALEPLON 10MG CAPSULE / ORAL AB RS 2008-06-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB RS 2008-06-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB RS 2008-06-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078989-001 ZALEPLON 5MG CAPSULE / ORAL AB 2008-06-06 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A078989-002 ZALEPLON 10MG CAPSULE / ORAL AB 2008-06-06 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base zaleplon
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZALEPLON 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination S62U433RMH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313761 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-1564-0 zaleplon 10 in 1 BOTTLE CAPSULE 10 11 50090-1564-1 zaleplon 30 in 1 BOTTLE CAPSULE 30 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-1564 ZALEPLON CAPSULE [A-S MEDICATION SOLUTIONS] 11 Current NDC, Legacy NDC, 2 package rows 20240108_8276a418-6a4c-4b81-8170-2d3838576c6d.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 6 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join zaleplon ZALEPLON PD-Rx Pharmaceuticals, Inc. 2cc7adee-2c4c-4fed-9914-545e70dba773 2025-10-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078989 application number: ANDA078989 zaleplon ZALEPLON Preferred Pharmaceuticals Inc. b0476859-07af-47f1-aec7-61aea0d99d24 2025-10-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078989 application number: ANDA078989 zaleplon ZALEPLON A-S Medication Solutions 8276a418-6a4c-4b81-8170-2d3838576c6d 2024-01-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078989 application number: ANDA078989 ndc (product): 50090-1564 zaleplon ZALEPLON Bryant Ranch Prepack d8c88122-ce04-4caf-bd4d-0a4368ea89ad 2023-11-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078989 application number: ANDA078989 zaleplon ZALEPLON Bryant Ranch Prepack b8032b14-5068-19d5-e063-839ed25d7200 2023-10-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078989 application number: ANDA078989 zaleplon ZALEPLON Unichem Pharmaceuticals (USA), Inc. 57a1a11d-7767-4caf-b98a-75d7561d9165 2021-06-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078989 application number: ANDA078989
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50090-1564-0 50090156400 10 CAPSULE in 1 BOTTLE (50090-1564-0) 10 capsule 2014-12-22 0000-00-00 No No Current 50090-1564-1 50090156401 30 CAPSULE in 1 BOTTLE (50090-1564-1) 30 capsule 2014-12-22 No No Current